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. 2023 Jun;46(6):575-585.
doi: 10.1007/s40264-023-01304-5. Epub 2023 Apr 27.

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Fariba Ahmadizar #  1 , Nicoletta Luxi #  2 , Monika Raethke  3 , Sandor Schmikli  1 , Fabio Riefolo  4 , Putri Widi Saraswati  1 , Camelia Bucsa  5 , Alhadi Osman  1 , Megan Liddiard  6 , Francisco Batel Maques  7 , Giuliana Petrelli  8 , Simona Sonderlichová  9 , Nicolas H Thurin  10 , Felipe Villalobos  11 , Gianluca Trifirò #  8 , Miriam Sturkenboom #  12 ; ilmiovaccinoCOVID19 collaborating group
Collaborators, Affiliations

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials

Fariba Ahmadizar et al. Drug Saf. 2023 Jun.

Abstract

Background and objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.

Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022. The results of previous pivotal clinical trials and data in the EudraVigilance were also analysed.

Results: The CVM study enrolled 658 first-dose vaccinees (children aged 5-11 years; n = 250 and adolescents aged 12-17 years; n = 408). Local/systemic solicited ADRs were common, whereas serious ADRs were uncommon. Among Comirnaty first and second dose recipients, 28.8% and 17.1% of children and 54.2% and 52.2% of adolescents experienced at least one ADR, respectively; injection-site pain (29.2% and 20.7%), fatigue (16.1% and 12.8%), and headache (22.1% and 19.3%) were the most frequent local and systemic ADRs. Results were consistent but slightly lower than in pivotal clinical trials. Reporting rates in Eudravigilance were lower by a factor of 1000.

Conclusions: The CVM study showed high frequencies of local solicited reactions after vaccination but lower rates than in pivotal clinical trials. Injection-site pain, fatigue, and headache were the most commonly reported ADRs for clinical trials, but higher than spontaneously reported data.

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Conflict of interest statement

Miriam Sturkenboom is head of a department that conducts studies for regulatory agencies and pharmaceutical companies, with research grants to the institution; this includes Pfizer, Janssen and AstraZeneca. All studies are conducted using the ENCePP code of conduct. Gianluca Trifirò has served in the last three years on advisory boards/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead, Amgen; he was the scientific director of a Master's program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received a non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also the scientific coordinator of the academic spin-off "INSPIRE srl" which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). None of these listed activities is related to the topic of the manuscript. Fariba Ahmadizar is the principal investigator of a Janssen COVID-19 vaccine safety study. None of the other authors has any conflicts of interest that are directly relevant to the content of this article.

Figures

Fig. 1
Fig. 1
A Key steps of the study projects and timing of the sending of the questionnaires. B Reported adverse drug reactions (ADRs) coding system. LIM Lareb Intensive Monitoring, RO ResearchOnline
See this image and copyright information in PMC

References

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